Smooth Minerals

Dosage form: lipstick
Ingredients: OCTINOXATE 225mg in 3g
Labeler: Avon Products, Inc.
NDC Code: 10096-0187

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DIRECTIONS: Apply liberally before sun
exposure and as needed.

WARNING:
Discontinue use if skin irritation develops
or increases. If irritation persists,
consult a health care practitioner

ACTIVE INGREDIENT/INGRÉDIENT
ACTIF: OCTINOXATE 7.50%

USES:Helps prevent sunburn. Higher SPF
gives more sunburn protection.

INACTIVE INGREDIENTS/
INGRÉDIENTS INACTIFS :
GLYCERYL
TRIACETYL HYDROXYSTEARATE, TRIISOSTEARYL
TRILINOLEATE, POLYGLYCERYL-2 DIISOSTEARATE,
CAPRYLIC/CAPRIC TRIGLYCERIDE,
POLYETHYLENE, POLYBUTENE, STEARYL/
PPG-3 MYRISTYL ETHER DIMER DILINOLEATE,
OZOKERITE, MICROCRYSTALLINE
WAX/CIRE MICROCRISTALLINE, C10-30 CHOLESTEROL/
LANOSTEROL ESTERS, CALCIUM
SODIUM BOROSILICATE, BARIUM SULFATE,
POLYGLYCERYL-3 DIISOSTEARATE,
PETROLATUM, PHENYL TRIMETHICONE, BUTYROSPERMUM
PARKII (SHEA BUTTER),SYNTHETIC FLUORPHLOGOPITE, ALOE BARBADENSIS
LEAF EXTRACT, THEOBROMA
CACAO (COCOA) SEED BUTTER, GLYCINE
SOJA (SOYBEAN) SEED EXTRACT, SACCHAROMYCES/
COPPER FERMENT, SACCHAROMYCES/
MAGNESIUM FERMENT, SACCHAROMYCES/
ZINC FERMENT, SACCHAROMYCES/
MALACHITE FERMENT, SACCHAROMYCES/
TOURMALINE FERMENT, ISOSTEARYL
ALCOHOL, SILICA, CAPRYLYL GLYCOL,
DISTEARDIMONIUM HECTORITE, TRIETHYL
CITRATE, TRILINOLEIC ACID, TOCOPHERYL
ACETATE, RETINYL PALMITATE, TIN OXIDE,
ALUMINA, TOCOPHEROL, CERAMIDE 3.
MAY CONTAIN/PEUT CONTENIR: MICA/CI
77019, TITANIUM DIOXIDE/CI 77891, IRON
OXIDES, CARMINE/CI 75470, BISMUTH
OXYCHLORIDE/CI 77163.

SMOOTH MINERALS 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0187
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE225 mg  in 3 g
Inactive Ingredients
Ingredient NameStrength
BARIUM SULFATE 
PETROLATUM 
PHENYL TRIMETHICONE 
ISOSTEARYL ALCOHOL 
CAPRYLYL GLYCOL 
TRIETHYL CITRATE 
MICA 
TITANIUM DIOXIDE 
BISMUTH OXYCHLORIDE 
Packaging
#Item CodePackage Description
1NDC:10096-0187-13 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/22/2009
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIOperations
Avon Products, Inc.001807106manufacture

Revised: 12/2009
 
Avon Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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